Article
Photopheresis at onset of type 1 diabetes: a randomised, double
blind, placebo controlled trial
J Ludvigssona, U Samuelssona, J Ernerudhb, C Johanssond, L Stenhammare, G Berlinc
a Division of
Pediatrics, Department of Health and Environment, Linköping
University, S-581 85 Linköping, Sweden, b Division of Clinical Immunology,
Department of Health and Environment, Linköping University, c Division of Transfusion Medicine,
Department of Health and Environment, Linköping University, d Pediatric
Clinic, Länssjukhuset Ryhov, Jönköping, Sweden, e Pediatric Clinic, Central Hospital,
Norrköping, Sweden
Correspondence to: Dr Ludvigsson Johnny.Ludvigsson{at}lio.se
Accepted 14 March 2001
BACKGROUND
In recent years
photopheresis, an extracorporeal form of photochemotherapy using
psoralen and ultraviolet A irradiation of leucocytes, has been claimed
to be an effective form of immunomodulation.
AIMTo evaluate its effect in type
1 diabetes we performed a double blind, controlled study using placebo
tablets and sham pheresis in the control group.
METHODSA total of 49 children,
aged 10-18 years of age at diagnosis of type 1 diabetes were included;
40 fulfilled the study and were followed for three years (19 received
active treatment with photopheresis and 21 placebo treatment).
RESULTSThe actively treated
children secreted significantly more C peptide in urine during follow
up than control children. C peptide values in serum showed
corresponding differences between the two groups. The insulin dose/kg
body weight needed to achieve satisfactory HbA1c values was always
lower in the photopheresis group; there was no difference between the
groups regarding HbA1c values during follow up. The treatment was well
accepted except for nausea (n = 3) and urticaria (n = 1) in the
actively treated group. There were no differences regarding weight or
height, or episodes of infection between the two groups during follow up.
CONCLUSIONPhotopheresis does have
an effect in addition to its possible placebo effect, shown as a weak
but significant effect on the disease process at the onset of type 1 diabetes, an effect still noted after three years of follow up.
Keywords: photopheresis; diabetes; photochemotherapy; placebo
© 2001 by Archives of Disease in Childhood
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